FDA 483 - Ionetix Corporation - January 19, 2024

An FDA inspection of Icnetix Corporation, a PET drug manufacturer in Pittsburgh, revealed deficiencies in equipment construction and quality unit oversight. Specifically, turbulent airflow was observed in an ISO-5 Laminar Air Flow Hood used for aseptic manipulation, and the firm's Quality Unit failed to establish proper protocols and documentation for smoke studies. These issues indicate potential risks to the quality and sterility of PET drugs.